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taVNS for Anxiety in ASD
NCT06258590 · View on ClinicalTrials.gov ↗
Study Summary
Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological wearable intervention used to manage anxiety and other neuropsychiatric symptoms at home, with patients/caretakers self-administering treatments. Each subject will undergo an initial in-person screening and be consented prior to participating in the study. This will be followed by an in-person training session with the subject (and caretaker if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS at home twice daily for 4 weeks. These treatments will not interfere with other aspects of their mental health care. Our investigators, over the prior 8 years, have demonstrated that taVNS is safe and feasible in the outpatient setting. Furthermore, investigators have recently demonstrated that taVNS is well tolerated and safely self-administered at home with remote monitoring. The investigators hypothesize that taVNS will be safe and feasible to administer at home in this new population. Results from this study may lead to further exploration of taVNS in this unique population.
Conditions Studied
Interventions
- DEVICE Transcutaneous auricular vagus nerve stimulation
Study Locations (1)
South Carolina
- Medical University of South Carolina — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2026-02-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06258590
The ClinicalTrials.gov registry entry for NCT06258590 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention — of which Transcutaneous auricular vagus nerve stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06258590 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06258590 about?
NCT06258590 is a clinical study titled "taVNS for Anxiety in ASD". Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacol...
What is the current status of trial NCT06258590?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-04-04. Estimated completion is 2026-02-24.
What conditions does trial NCT06258590 study?
This clinical trial studies the following conditions: Anxiety, Autism Spectrum Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06258590?
The interventions under investigation include: Transcutaneous auricular vagus nerve stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06258590?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06258590 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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